VeriCyn Wound Wash receives FDA 510(k) clearance
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Key takeaways:
- The FDA has given 510(k) clearance to Armis’ VeriCyn Wound Wash.
- The device is indicated for pressure ulcers, diabetic ulcers, surgical wounds, burns and grafted/donor sites.
The VeriCyn Wound Wash medical device by Armis Biopharma has received 510(k) clearance from the FDA for use in cleansing wounds of debris, according to a company press release.
“VeriCyn is the first FDA-cleared product for wound care from Armis Biopharma, opening the door to future wound and skin care products for the company,” Ted Ziemann, chairman and CEO of Armis Biopharma, told Healio. “It demonstrates the key attributes of our technology: proven efficacy for intended purpose, safe to use, safe for the environment, and does not contain potentially harmful chemicals like chlorine or steroids.”
VeriCyn Wound Wash, which is free of chlorine, alcohol and surfactant, uses a lavage system to create mechanical movement at the wound surface allowing for the clearance of foreign material, micro-organisms and debris.
The device can be used for stage I to stage IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first degree burns, partial thickness burns and grafted/donor sites.
According to Ziemann, the clearance was based on multiple studies under good laboratory practices and good manufacturing practices, including product efficacy, safety and stability.
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